Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, has submitted a protocol to the US Food and Drug Administration (FDA) to initiate a phase IIa trial of its orally ingestible insulin capsule, ORMD 0801, for type 1 diabetes.
The protocol was submitted under Oramed's existing IND for ORMD-0801 to include both type 1 and type 2 diabetes indications. The double-blind, randomized, placebo controlled, seven-day study design will be carried out at an inpatient setting on twenty-four type 1 diabetic patients. This US- based study is expected to start later this quarter.
"With the encouraging data from our recent phase IIa FDA trial on type 2 diabetic patients, we are moving forward on both the type 1 and type 2 indications by submitting this type 1 protocol to the FDA while gearing up for the phase IIb multi-center trial on type 2 patients to take place later this year," commented Oramed CEO Nadav Kidron.
Oramed proposes to introduce ORMD-0801 to reduce the mealtime insulin doses, introducing a treatment regimen which would allow for fewer daily injections. Moreover, oral administration offers the benefit of reduced systemic exposure and may enable tighter regulation of blood sugar levels by directly affecting glucose control in the liver.
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines currently delivered via injection.